Protocol summary

Summary
Increase of pain intensity and labor duration has adverse effects on mother and fetus. Lack of prenatal preparation courses in pregnant women increase complications and medical interventions for mother and fetus. Taking part in these courses can solve these problems. This clinical experimental trial study was designed on 136 primiparous women who referred to Motazedi Hospital in kermanshah in 2009. Samples include primiparous women without any medical and midwifery complications that will participate in the study from 20 weeks of pregnancy. They will be randomly divided to experimental and control groups. Mothers in experimental group will be trained in 8 sessions ( each session last 90 minutes)while those in control group will receive routine care only. The collected data will analyze. Pain intensity, second stage duration of labor will compare between two groups.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201105286618N1
Registration date: 2011-07-21, 1390/04/30
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2011-07-21, 1390/04/30
Registrant information
Name
Marzieh Sfandiary
Name of organization / entity
Kermanshah university of medical sciences
Country
Iran (Islamic Republic of)
Phone
+98 83 1828 2101
Email address
sfandiarymarzieh@kums.ac.ir
Recruitment status
Recruitment complete
Funding source
Kermanshah university of medical sciences
Expected recruitment start date
2011-04-27, 1390/02/07
Expected recruitment end date
2012-04-26, 1391/02/07
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of prenatal preparation for childbirth courses on pain intensity, second stage duration of labor in primiparous women referred to Motazedi hospital of Kermanshah,2010
Public title
The effect of prenatal preparation for childbirth courses on labor process
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: Primiparous women and gestational age more than 20 week Exclusion criteria: Medical and midwifery complications such as threatened abortion, multiple pregnancy, bleeding, hypertension,PROM and preterm labor
Age
No age limit
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 136
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Kermanshah university of medical sciences
Street address
Department2, SHahid beheshty street
City
Kermanshah
Postal code
Approval date
2011-04-27, 1390/02/07
Ethics committee reference number
پ / 7 / 420 /4941

Health conditions studied

1

Description of health condition studied
Delivery
ICD-10 code
080.0
ICD-10 code description
Spontaneous vertex delivery

Primary outcomes

1

Description
Pain intensity
Timepoint
After intervention and after delivery
Method of measurement
Visual analog scale

2

Description
Duration of second stage of labor
Timepoint
After intervention and during delivery
Method of measurement
Minute

Secondary outcomes

empty

Intervention groups

1

Description
Mothers in experimental group (n=68) will be trained in 8 sessions ( each session last 90 minutes that includs 45 minutes theorical subjects, 15 minutes of discussion and 30 minutes of stretching and breathing exercises and position improving). Tools includ information form and visual analog scale. The collected data will analyze. Pain intensity, second stage duration of labor will be measured in experimental group duringdelivery.
Category
Prevention

2

Description
Mothers in control group will just receive routine prenatal care without any intervention. then Pain intensity, second stage duration of labor will be measured in control group during delivery.
Category
Prevention

Recruitment centers

1

Recruitment center
Name of recruitment center
Motazedi Hospital
Full name of responsible person
Sfandyari Marzieh, Midwifery MSc
Street address
Ferdosi Sq, Kermanshah
City
Kermanshah

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Financial Unit
Street address
DEPARTMENT1, SHAHID BEHESHTI STREET
City
Kermanshah
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kermanshah University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty

Person responsible for general inquiries

Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Sfandiary Marzieh
Position
Midwifery MSc
Other areas of specialty/work
Street address
MIDWIFERY AND NURSING UNIVERSITY, EISAR SQUARE, KERMANSHAH
City
Kermanshah
Postal code
Phone
+98 83 1828 2101
Fax
Email
sfandiarymarzieh@yahoo.comsfandiarymarzieh@kums.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Sfandiary Marzieh
Position
Midwifery MSc
Other areas of specialty/work
Street address
UNIVERSITY OF MIDWIFERY AND NURSING, Eisar Sq
City
Kermanshah
Postal code
Phone
+98 83 1828 2101
Fax
Email
sfandiarymarzieh@yahoo.comsfandiarymarzieh@kums.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Sfandiary Marzieh
Position
Midwifery MSc
Other areas of specialty/work
Street address
UNIVERSITY OF MIDWIFERY AND NURSING, EISAR SQUARE
City
Kermanshah
Postal code
Phone
Fax
Email
sfandiarymarzieh@yahoo.comsfandiarymarzieh@kums.ac.ir
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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